Stanford

GUIDANCE — Items to consider

SDD

Spectrum support for Clinical Research is divided into four stages, the first of which is DESIGNING YOUR STUDY.

This stage includes tasks and activities that occur early in the design & development of a study, such as:

  • biostatistics consultations
  • informatics consultations
  • bioethics consultations
  • identifying co-investigators and collaborators
  • exploring funding opportunities

The clinical research process for clinical and translational research projects, from study idea and design through close-out and publication, requires consideration and often consultation with appropriate experts regarding:

Getting Started

  • Do I need help with my study design?
  • What is a Case Report Form and how do I create one?
  • Can I do my study at Stanford?
  • What resources are available to support my project?

Regulatory Requirements

  • What are FDA requirements?
  • Do I need IRB approval?
  • Do I need an IND or IDE for my research project?
  • What does it mean to be a Sponsor-Investigator?
  • What documents are essential for my research?

Budget and Billing Matters

  • What is RMG and who is my RPM?
  • What is Medicare Pre-authorization?
  • How do I get started with my budget?
  • Who do I contact for billing issues?
  • What is the workbook?

Staffing Needs

  • Do I need a coordinator?
  • What does a coordinator do?
  • How much will a coordinator cost?

Grant and Contract Processes

  • When do I need a contract?
  • What is the Office of Sponsored Research (OSR) and who is my contract officer?
  • How do I finance my study?
  • Do I need a contract if I am getting equipment on loan?
  • Who do I contact about my grant?